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Current Openings
| Clinical Study Coordination |
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Role :
- Assists the clinical investigator in efficiently executing the logistics of all clinical studies at the CRO
Responsibilities :
Primary :
- To assist in preparation of protocol and its appendices
- To interact with the caterer to ensure timely provision of meals as per approved meal plans
- To ensure sufficient numbers of ICFs are available in the required languages to obtain the informed consent before start of the study
- To make logistical provisions required by the protocol: path lab, clinical supplies, water, meals, etc.
- To check vital signs sheet and adverse events monitoring sheets of subjects along with all raw data form
- To monitor safety parameters during clinical studies
- To write and revise SOPs and ensure compliance with all current policies and procedures
- To assist in compilation of raw data related to safety of subjects
Secondary :
- To be available at centre during in house part of study to handle medical emergencies
- To check vital signs sheet and adverse events monitoring sheets of subjects
- To review medical screening records and ascertain suitability of subjects
- Volunteer selection, informed consent procedure as per defined procedure
- To conduct clinical examination of all subjects participating during all clinical studies
- Preparation of clinical report and study update
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| Quality Control (Bioanalytical Section) |
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Role :
- Assist Head- Bioanalytical in ensuring GLP and applicable regulatory compliance to achieve and maintain desired quality standards
Responsibilities :
- Ensuring strict compliance with GLP norms in the bioanalytical section
- Monitoring compliance with Standard Operating Procedures
- Checking documentation for every procedure carried out from Analysis to reporting of results
- Preparation of Standard Operation Procedures for various activities
- To coordinate monthly training sessions for the bioanalytical staff
- To impart training to all personnel for implementation of quality systems
- Preparation of the department for External Audits & Inspections
- Preparation of training schedule for the new employees
- Conduct of regular QA Audits to verify compliance to Quality Systems
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| Analyst |
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Role :
- Assists the Group Leader Bioanalytical in the lab operations and execution of the study as per GLP and applicable regulatory standards
Responsibilities :
- To participate in the day-to-day activities related to method development, method validation and study sample analysis in the lab in consultation with the group leader/ senior Analyst
- To procure and maintain reference standards, reagents, analytical columns etc
- To initiate, check and supervise the calibration/maintenance of equipment (HPLC, LC-MS/MS etc.
- To assist the senior scientist for checking/review of all SOPs including method SOPs, method validation reports and bioanalytical reports of the projects
- To anticipate and plan project related purchase activities
- To monitor the receipt of study samples from clinical unit
- Collection of literature for the projects on method development and validation
- Study related documentation
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| Instrumentation Engineer |
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Role :
- Assists the Head - Clinical / Bioanalytical operations to provide GLP support on maintenance, calibration and validation of instruments
Responsibilities :
- Ensure smooth functioning of the instruments by coordinate with supplier and vendors
- Maintenance of Instruments/equipments spare parts & inventory
- Maintenance of Eurotherm temperature recording system for freezers and cold room
- Maintenance of centrifuges
- Ensure appropriate documentation in instrument/equipment logbooks
- Calibration of all instruments and equipments
- Updating SOPs for all instruments and equipments
- Ensuring Preventive maintenance of all instruments and maintaining the schedules
- Maintenance of IQ/OQ/PQ documents of all instruments
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| Quality Control - Clinical |
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Role :
- Assist the Head, Clinical Operations in implementing quality control activities by verifying the trial- related activities for fulfilling ICH-GCP, GLP requirements in all clinical studies at the CRO.
Responsibilities :
- To assess and implement quality control measures at all levels to increase efficiency and work standard.
- To ensure studies are more compliant with SOP, Protocol and applicable regulatory guidelines.
- To conduct online checks during study to increase quality and to prevent sponsor and quality assurance observations.
- To impart training on relative SOPs’ and quality programme.
- To assist Head, Clinical Operations to maintain timelines in the conduct of study procedures and training.
- To conduct meeting and to discuss quality assurance audit observations and prevent recurrence.
- To review and modify the required clinical/general SOP as need arises.
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